Wire closures are widely represented in the contemporary art as a recognized means for closing the sternum following a mid-line sternotomy. Examples of such contemporary closure systems are marketed under a variety of device/methodology names including but not limited to the Hemostatic Sternal Closure® system which proclaims to be a major innovation based upon proven principals and cardiovascular surgery. At the time of this writing further documentation with respect to the Hemostatic Sternal Closure System may be found at the website http://www.alpha-research.com.products—4_cc_hsc.html. Another example of a wire dependent closure system is marketed under Pectofix Surgical Technique Information with respect to deployment of this technique and its associated device can be found at the website http://www.pectofix.com/technique.shtm.Other wire closure systems are known to those skilled in the art, have been used in the past, and indeed continue to be used with less than desirable results.
Widely recognized deficiencies with respect to wire based closure devices include an implementation/deployment time typically averaging 15–20 minutes per mechanism. Such an excessive time requirement translates, of course, into increased operating room costs, increased doctor, staff and insurance costs, and increased doctor fatigue. Perhaps of greater significance however are the numerous stresses caused and long associated with deployment of wire based sternum closure devices including patient pain, patient infection, pneumonia, tissue tears, wire disengagement and loosening, chest openings, and post-op emergent returns. All the afore-noted conditions result from inexact and undue stress conditions associated with wire closure devices in turn, and consistently result in slower patient discharges and unnecessary costs for the patient and community. In stark contrast, the instant invention requires an implementation time that is reduced by more than 90% from that of wire devices requiring only one to two minutes implementation time per clamp, virtually eliminates multi-lateral stresses through physics and strength, and totally eliminates the necessity for bone punctures required of wire suture based devices.
A variety of sternal disruptive forces exasperate the very intention of wire based systems. Forces associated with sternonomies include but are not limited to the rectus abdominus muscle exerting an uneven pull, a lateral pull by pectoralis muscles, forces generated by valsalva action and anterior/posterior displacement of hemi-sternum via respiratory muscle action. With respect to contemporary art wire based systems, such disruptive forces typically result in one or more of the following conditions: (a) wires cutting into bones; (b) sternal fragmentation; (c) broken wires; and (d) off-side sternotomy.
In view of the deficiencies of wire based clamping surgical devices, and further in view of the life threatening conditions associated with failure of such devices, newer technology has been recognized as superior to the wire devices. Stated succinctly, such devices are generically referred to as clamp closures. Though other clamp closure devices have been presented as effectuating an improvement over wire devices, no contemporary clamp closure provides the novel aspects and benefits afforded by the instant device for capturing, positioning and aligning portions of a severed human sternum via the device's unique structure for capturing and positioning the costal cartilage (notch) portion of each of a paired set of ribs located on opposite sides of a severed sternum while simultaneously contacting and substantially surrounding the anterior and posterior portions of the sternum and thereby preventing severed sternal halves from moving relative to one another and precluding rostral and vertical bone shearing travel. Consequently, the unique structure of the instant invention addresses and resolves many of the problems associated with contemporary wire systems, and indeed, contemporary clamp closures.
U.S. Pat. No. 6,051,007 issued Apr. 18, 2002 to Mike Hogendijk and Troy Chapman, subsequently assigned to Coravascular Incorporated and filed May 2, 1998 purports to disclose and claim a sternal closure device comprising first and second clamps. The first and second clamps have a generally tubular portion and the second clamp has a portion that is slidably receivable in the tubular portion, and a lock configured to retain said second clamp within said first clamp. A surgical instrument for laterally moving opposed sternal clamps toward one another is also disclosed. The instrument comprises first and second grasping members generally linearly slidably coupled to one another.
As clearly distinguished from the instant invention the benefits, teachings and claims of the '007 patent lack the multiplicity of sternum engagement services and more importantly the “surrounding” capability of the instant invention with respect to anterior and posterior sternal halves as well as opposing rib members of a rib pair located on either side of the severed sternum. Such distinguishing characteristics allow for superior assistance with respect to normal pulmonary mechanics; enhance positioning and accelerate recuperation time associated with procedures requiring the severing of human sternum.
U.S. Pat. No. 6,217,580 B1 purports to disclose and claim a method of closing a patient's sternum following a sternotomy as indicated with respect to U.S. Pat. No. 6,051,007 above the '580 patent, though issuing a year subsequent to that of Hogendijk ('007 patent) continues to lack the resilience positioning and capturing benefits and claims of the instant invention. Though the '580 patent is limited to a method relating to the closing of a patient's sternum it is to be noted that the '580 patent relies upon bringing opposed legs of clamp members into overlapping relationship to one another in sharp distinction to the instant invention. Such overlapping relationship and reliance upon countersunk regions of a clamp member to present a substantially flush upper surface does not provide for the securing strength offered by the insertable relationship of the instant invention with respect to insertion guide and insertion guide members. Further and perhaps of greater importance, like the '007 patent, the '580 patent continues to present deficiency with respect to preventing rostral and vertical sheering of severed sternum halves in that it fails to capture or combine the positioning/securing benefits of aligning severed sternal halves in combination respective rib pair members.
U.S. Pat. No. 4,201,215 issued May 6, 1980 to E. S. Crossett L. L. purports to disclose and claim an apparatus and method for closing a severed sternum. The device of Crossett, as disclosed, is dimensionally deficient with respect to the rib capturing and positional expectancies of the instant invention. More specifically, the devise of Crossett is intended to be deployed between subsequent sets of rib pairs as opposed to capturing (surrounding) rib pairs attached to either half of a severed sternum. Further, the devise of Crossett does not provide the pulmonary assistance offered by the instant invention in that it would appear the body portion of the Crossett devise relies upon structural displacement across the posterior portion of the sternum. Such positioning and structural dynamics render the Crossett device incapable of presenting the angularity offset required to evenly match and align the anterior portions of the severed sternum without inducing undue stress.
In addition to enhancing the art beyond that of contemporary art sternum closure devices, the instant invention provides benefit to the following: patients, doctors, hospitals and insurance. For patents, the rapid and effective implementation of the present invention results in lower patient pain, infection, bleeding, requires fewer blood transfusions, fewer post-op emergent returns and greater satisfaction. For doctors benefits include but are not limited to ease of application, less fatigue, better efficacy rate, less time in the operating room and more time with patients or their families. For hospitals, the efficiency of the present invention results in lower numbers of corrective procedures, lower operating room costs (less time), lower doctor/staff costs. With respect to insurance coverage benefits, the present invention facilitates lower up front costs as it deployment induces less infections, less bleeding and less time under anesthesia. All resulting in lower risk to the patients, lower back end costs with lower post-op emergent returns, and indeed, lower overall hospital costs.